FDA recall D-0155-2018

Product

Gabapentin Tablets, USP, 800 mg, 500-count, Rx only, Made in India, PONDRUGS/16 134193, Distributed by: Solco Healthcare US, LLC, Cranbury, NJ, 08512, USA. NDC 43547-0333-50

Reason for recall

Labeling: Label Mix-Up.some bottles labeled as Gabapentin 800 mg contain Gabapentin 600 mg

Distribution

Product was distributed in Mason, OH.

Key facts

Status

Terminated

Initiation date

2017-12-04

Report date

2018-01-17

Termination date

2019-02-25

Voluntary/Mandated

Voluntary: Firm initiated

Location

Cranbury, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0155-2018